NCT01519713

Study of a Single Dose of Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine (SP284) in Japanese Subjects

Immunogenicity and Safety of a Single Dose of a Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (SP284) in Japanese Subjects

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 2 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study is designed to assess the safety and immunogenicity of a single dose of Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (SP284) to support registration of the product in Japan. Primary Objective: * To describe the seroprotection rate \[% of subjects with serum bactericidal assay using baby rabbit complement (SBA-BR) ≥1:128\] to meningococcal antigens (serogroups A, C, Y and W-135) following vaccination with SP284 vaccine in subjects 2 through 55 years of age Secondary Objectives: * To describe the safety following receipt of SP284 vaccine in subjects 2 through 55 years of age * To describe the immune responses to meningococcal antigens (serogroups A, C, Y and W-135) following vaccination with SP284 vaccine in subjects 2 through 55 years of age.

Detailed description

All participants will receive a single injection of Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate vaccine on Day 0 and undergo immunogenicity assessment and safety monitoring post-vaccination.

Conditions

• Meningitis
• Meningococcal Meningitis
• Meningococcal Infections

Interventions

Type	Name	Description
BIOLOGICAL	Meningococcal polysaccharide diphtheria toxoid conjugate	0.5 mL, Intramuscular

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-09-01
• Completion: 2012-12-01
• First posted: 2012-01-27
• Last updated: 2013-05-28
• Results posted: 2013-05-28

Locations

3 sites across 1 country: Japan